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Completed

NCT Number: NCT04357795

Effect of Cequa™ in Subjects With Dry Eye Disease

This is a Phase 4, multicenter, single arm, 12 week study in subjects with dry eye disease, which is inadequately controlled by cyclosporine 0.05% ophthalmic emulsion.

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Key information

Conditions

Dry Eye Disease Conjunctival Diseases Conjunctivitis Corneal Diseases Dry Eye Syndromes Eye Diseases Keratitis Keratoconjunctivitis Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Eye Associates of Fort Myers, 4225 Evans Ave., Fort Myers, Florida, United States

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About this study

This is a phase 4, multicenter, open-label, single-arm, 12-week study of subjects with dry eye disease that is inadequately controlled by cyclosporine (CsA) 0.05% ophthalmic emulsion. Subject enrollment will be classified by evidence of dry eye disease (ie, signs, symptoms, or both signs and symptoms). Treatment will be one drop of CsA 0.09% ophthalmic solution (Cequa) in each eye twice daily (BID) for 12 weeks. The study hypothesis is that CsA 0.09% ophthalmic solution will show improved clinical benefit in subjects whose dry eye signs and/or symptoms are inadequately controlled while on CsA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects with a history of bilateral dry eye disease for a period of at least 3 months.
  • Aged of at least 18 years.
  • Subjects with total corneal fluorescein staining ≥6 or corneal fluorescein staining in an individual zone ≥2 as per National Eye Institute Grading Scale.
  • Subjects with modified symptom assessment in dry eye global symptom score, ≥40 using visual analogue scale.
  • Subjects with best-corrected visual acuity 20/200 or better in both eyes at the Screening/Baseline visit

Exclusion criteria

  • Subjects who have used cyclosporin 0.05% ophthalmic emulsion in both eyes for less than 3 months prior to the Screening/Baseline visit.
  • Subjects with history of treatment failure with cyclosporin 0.05% ophthalmic emulsion.
  • Subjects who have active seasonal and/or perennial allergic conjunctivitis in either eye.
  • Subjects who had already Use initiated any systemic or topical ocular medication.

Treatment and study plan

CequaTM (Cyclosporine 0.09%) ophthalmic solution

Drug

One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.

Primary outcomes

  1. Mean Change in Baseline in Total Corneal Fluoroscein Staining Score

    Time frame: Week12

    Scale for Corneal Staining as defined by the FDA/NEI: 0-4 (0-no staining, 4-severe staining). The higher number indicates more severe. The lower the number indicates less severe staining on the cornea

  2. Change From Baseline in Modified Dry Eye Scoring.

    Time frame: Week12

    Based on questionnaire asked to subjects (sign and symptoms), modified symptom of dry eye score (range 0 to 100) will be assessed. Increase in score will indicate severity in the symptoms.

Secondary outcomes

  1. Mean Change in Baseline for Conjunctival Staining Assessment

    Time frame: Week 12

    Based on Investigator's judgement, 6 areas of the conjunctiva will be evaluated in a low to moderate intensity.

    Scale for Conjunctival Staining defined: 0-6 (0 no staining, 6-severe staining). The higher the number indicates more severe. The lower the number indicates less severe staining on the conjunctival

  2. Changes From Baseline in Central Corneal Staining Score

    Time frame: Week 12

    Five areas of cornea will be evaluated on a 0 to 4 scale and value from 0 (absent) to 4 (severe) to each section will be allotted based on NEI grading scale

  3. Mean Change in Baseline for Tear Osmolarity Score for Both Eyes

    Time frame: Week 12

    Tear osmolarity of both the eyes will be assessed and score (mOsm/L) will be allotted to each eye. Higher score will indicate severity of the disease (dry eye).

    Tear osmolarity OU was assessed using the TearLab Osmolarity System Test by collecting nanoliter volumes of tear fluid at each visit from each eyelid margin using the Osmolarity Test Pen and Test Card. Results were interpreted according to the provided instructions and scores (mOsm/L) for each eye were recorded. Normal, mild/moderate, and severe dry eyes had average tear osmolarity values of approximately 302+/-8 mOsm/L, 315+/-10 mOsm/L and 336+/022 mOsm/L, respectively.

  4. Mean Change From Baseline in Frequency of Artificial Tear Product Use.

    Time frame: Week 12

    Based on entries in the subject diaries, frequency of artificial tear product use will be assessed.

    Frequency for artificial tear: This is number of times per day recorded in a daily diary log assessed at baseline and week 12. The higher the number the worse the outcome. The lower the number the better the outcome

  5. Schirmer's Test Score

    Time frame: Week 12

    An unanesthetized Schirmer's test was performed in each eye at least 5 minutes after the lissamine green conjunctival staining to allow for any reflex tearing to subside. At each visit, strips were placed OU at the same time and timed for 5 min. Strips were removed after 5 min and the amount of wetting was recorded in mm and also marked with a line on the strip. The Investigator recorded a score for each eye. A score of greater than 10 mm in 5 minutes is accepted as normal. A score of less than 5 mm in 5 minutes indicates a tear deficiency. A score less than 10 mm in 5 minutes indicates a change from normal in tear production.

  6. Percentage of Subjects Who Prefer Study Treatments Over Prior Treatment.

    Time frame: Week 12

    Subjects will be asked, which treatment they prefer for the management of the dry eye (prior treatment or study treatment).

    Note- For this outcome measure, participants were provided the option to not choose either treatment as the preferred treatment.

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries Limited

Industry

Registry information

Official study title

Effect of Cequa™ in Subjects With Dry Eye Disease That Is Currently Inadequately Controlled While on Cyclosporine 0.05% Ophthalmic Emulsion

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2020
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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